vertex

MedImmune, big biotechs plot major 2009 expansion

John Carroll — Mon, 01 Dec 2008 10:32:22 -0500

Biotech companies are being rapidly divided among three distinct classes: growing biotechs worth more than a billion dollars, survivors with money in the bank and a growing segment of downsizing small and mid-sized companies.

MedImmune, for example, has blueprinted a 300,000-square-foot expansion of its corporate headquarters in Gaithersburg, MD, almost doubling the amount of HQ space it has. The expansion is largely new lab space, which will accommodate 600 employees. And MedImmune plans to go ahead and hire another 800 people next year, on top of the 800 it hired this year.

Meanwhile, even though much of the rest of Boston's economy is in a tailspin, the city's largest biotech companies are enjoying a surge in growth, with many hiring for dozens of open positions. Biogen Idec is hunting for new personnel to fill 106 positions, according to the Boston Business Journal, while Genzyme is advertising more than 100 jobs and Vertex is recruiting 89.

"We've added 10 percent to our workforce over the past year," Scott Santoro, senior director for talent acquisition at Biogen, tells the Business Journal. The fast growth is happening at biotechs with a market cap north of $1 billion.

- check out the report in the Washington Business Journal
- read the story in the Boston Business Journal

Vertex readies new Phase 3 trial of telaprevir

John Carroll — Tue, 19 Aug 2008 12:09:56 -0400

Vertex and partner Johnson & Johnson have struck agreements with regulators on both sides of the Atlantic for a new Phase III trial of the closely-watched telaprevir for hepatitis C. This new late-stage study will test the therapy in 650 refractive patients and is intended to build on the data due from a separate trial of telaprevir in treatment naïve patients.

Vertex's share price has been tied to the fate of telaprevir, rising and falling with the drug's prospects. TheStreet notes that the developer isn't likely to file for approval of the drug until the second half of 2010, when it has the data on the treatment naïve group. A smaller study in treatment resistant patients has demonstrated efficacy for attacking the virus.

--see the Vertex release
--read the story from TheStreet.com

Schering-Plough posts positive hep C data

John Carroll — Mon, 04 Aug 2008 12:12:20 -0400

Schering-Plough published promising new data for its experimental hepatitis C drug boceprevir, which pushed down the share value of rival Vertex Pharmaceuticals. After 48 weeks of therapy, researchers said, three out of every four patients receiving boceprevir in combination with standard therapy had undetectable levels of the virus. That compares to 38 percent with undetectable viral levels in the standard therapy arm.

None of that Phase II data is likely to sway analysts who pegged Vertex's closely watched telaprevir as the likely winner in the race to an FDA approval. But hepatitis C is a very competitive disease field, and a rival therapy could quickly eat into its revenue. Vertex shares lost 11 percent on the news from Schering-Plough.

- check out Schering-Plough's release
- read the report from StreetInsider

Vertex shares rise on positive data for telaprevir

John Carroll — Mon, 09 Jun 2008 11:52:41 -0400

Vertex Pharmaceuticals saw a significant bump in its share price this morning after researchers released new, mid-stage interim data backing telaprevir for hepatitis C. The company is now penciling in the start of a new late-stage trial for the closely watched drug--enrolling patients who had failed standard therapy--in the third quarter. The new data is from a Phase IIb involving patients who had failed a standard therapy.

In the study, patients received telaprevir in combination with interferon/ribavirin for 12 weeks, then the combination therapy for the next 12 weeks followed by 12 weeks of neither therapy. The control arm received the combination therapy for 36 weeks. Slightly more than half of the telaprevir group had undetectable levels of the virus after 36 weeks compared to 30 percent in the control group. A late stage trial for the hep C drug began in spring with patients who had received no prior therapy.

- check out the press release
- read the AP report

Tercica shares skyrocket following takeover bid

Fri, 06 Jun 2008 06:59:54 -0400

Moving fast, investors swiftly bid up the value of Tercica's stock yesterday afternoon after hearing that France's Ipsen would pay $9 a share to acquire all the stock in the company it didn't already own. That was more than $4 a share above what Tercica has been trading at. One unexpected mover was Vertex, which jumped after an analyst predicted that its closely watched hepatitis C drug telaprevir would be approved earlier than expected.

- read the AP story

Vertex drug improves lung function in IIa CF trial

Thu, 27 Mar 2008 07:59:57 -0400

After stumbling on high investor expectations for its experimental hepatitis C therapy, telaprevir, Vertex garnered a dose of good news with the release of positive Phase IIa data on VX-770 for cystic fibrosis. Researchers reported that the small, 20-patient study revealed improved lung function in patients taking the oral drug. There was no discerned improvement in patients taking a placebo. Vertex shares jumped 10 percent on the news.

"While these are early data, it is unprecedented for an investigational oral compound for the treatment of CF to have such a marked effect on multiple measures of CF disease activity. We saw an average improvement in lung function of 10 percent in patients receiving the highest dose, compared to no observed improvement in patients who received placebo," said Frank Accurso, M.D., Director of the Cystic Fibrosis Center and Professor of Pediatrics at the University of Colorado School of Medicine in Denver.

"More than 10 years ago, the Cystic Fibrosis Foundation believed that Vertex's approach to treating CF by directly targeting CFTR function--the underlying mechanism of the disease--was an important opportunity to meaningfully change the course of cystic fibrosis," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation.

- see the release
- read the AP report on the data

Related Articles:
Red tide research points to cystic fibrosis therapy. Report
Investors disappointed in Vertex despite strong data. Report
Vertex refines terms on $300M public offering. Report

ALSO NOTED: AstraZeneca may shake up R&D with spin-off; Vertex sells stock; and much more...

Tue, 12 Feb 2008 06:59:50 -0500

> AstraZeneca is considering spinning off its GI research institute into a separate company that would go out into the market and hunt for venture capital backing, according to Swedish newspaper reports. The news reports say that the pharma company is looking at spinning off five research projects. Report

> Vertex plans to sell 6 million common shares as well as $250 million in convertible senior subordinated notes due 2013. Report

> Belgium's Innogenetics says it plans to shelve new investments at its therapeutics business Genimmune. Report

> Docs needing blood-thinning drugs may be in a fix. Allergic reactions prompted Baxter to stop making multiple-dose vials of heparin, and the FDA told physicians to stop using them except when absolutely necessary--and then, very carefully. Report

> Finally, someone asked the question we've been wanting to ask ourselves: Even if the Enhance study data remained blinded, could Merck or Schering-Plough have divined its overall sway? Sen. Charles Grassley, who's been shooting out letters to the two companies at the rate of at least two a week, made the query in another round of correspondence yesterday. Report

> Schering-Plough, Sanofi and Teva have announced their earnings. Report

> While they were reporting their earnings, Schering-Plough and Sanofi-Aventis executives both found themselves on a hot seat. Report

> A protein may hold the key to a new vaccine that could effectively target pneumonia, according to Children's Hospital of Pittsburgh of UPMC. Report

> If you can't afford $350,000 to have your genome sequenced, wait awhile. The price is dropping fast. Report

And Finally… The World Health Organization says that without urgent action a billion people will be killed by tobacco this century. Release

Hep C drug promises to "blow market wide open"

Mon, 26 Nov 2007 06:59:55 -0500

For almost 15 years now Vertex has been patiently advancing its work on a new therapy for hepatitis C. Forbes profiles the long and winding research road, with plenty of new pitfalls being created by other hep C therapies that have popped up to take the limelight away from Vertex's telaprevir. A new approach will match polymerase inhibitors with protease inhibitors to rev up response rates.

"We are going to have much higher response rates in the very near future. It is going to blow the market wide open," Mount Sinai School of Medicine's Douglas Dieterich, who is testing a compound from Roche, tells Forbes.

- check out the article from Forbes

ALSO: Roche, meanwhile, has returned the rights to the experimental hep C drug R7025 to Maxgen. Two months ago Roche put a hold on the program. Report

Related Articles:
Investors disappointed in Vertex despite strong data. Report
Vertex hep C drug impresses in Phase IIb. Report
Vertex inks rich pact with J&J. Report
Vertex refines terms on $300M public offering. Report
Vertex gets good news for RA drug. Report

Merck halts leukemia trials after adverse event

Wed, 21 Nov 2007 06:59:58 -0500

Vertex says that Merck suspended two clinical trials of the leukemia drug MK-0457 after one of the patients in the study developed a heart condition--QTc prolongation--caused by a disruption in the organ's electrical system. Researchers called for a full review of the data available on the drug, which is in Phase II as the lead Aurora kinase inhibitor included in a development pact between the two companies. The drug is also in an early-stage combination trial with dasatinib. Another Aurora kinase inhibitor included in the collaboration, MK-6592, has been dumped after it failed to deliver on its pharmacokinetic goals in Phase I.

- see this release
- check out the AFX report for more

Related Articles:
Vertex shares jump on hep C trial data. Report
Analysts cheer signs of turnaround at Merck. Report

Investors disappointed in Vertex despite strong data

Mon, 05 Nov 2007 06:59:57 -0500

Vertex shares sank on Friday after the company reported that its closely-watched hepatitis C drug telaprevir eradicated the virus in more than 60 percent of patients. Standard therapies on the market have a success rate of 50 percent or less, making telaprevir a clear favorite. But Vertex has been the subject of considerable speculation, with some analysts looking for efficacy rates of around 70 percent for the hepatitis C drug. With plenty of competition in the field, investors took a look at what most biotechs would consider a clear winner and sent shares down about nine percent.

The money men on Wall Street appeared to be particularly concerned by dropout rates of 18 percent and 12 percent in the Phase IIb studies and a lack of data from the control arm, which dosed patients with a combination of pegylated-interferon and the antiviral drug ribavirin.

- see this release
- check out the AP report on telaprevir

Related Articles:
Vertex hep C drug impresses in Phase IIb. Report
Vertex inks rich pact with J&J. Report
Vertex refines terms on $300M public offering. Report
Vertex gets good news for RA drug. Report

Idenix sees little hope for hep C candidate

Fri, 13 Jul 2007 06:59:58 -0400

Cambridge, MA-based Idenix is preparing a formal burial for valopicitabine, an experimental therapy for hepatitis C. CEO Jean-Pierre Sommadossi says he believes that the FDA's decision that the drug's risks outweigh its benefits leaves the drug "with no future for clinical development." Idenix has to discuss the funeral details with Novartis, which partnered up on the drug, but those kinds of remarks leave little room for reversal. Idenix technically put the development program for NM283 on hold. Investors shifted gears fast, sending the company's stock down about 22 percent.

'We remain committed to building a leading antiviral franchise and will continue to focus on ensuring a successful launch of Tyzeka/Sebivo (for hepatitis B) and on advancing our pipeline,' said Sommadossi.

- see the release
- check out this AFX report

ALSO: Idenix's loss is Vertex's gain. Vertex is developing a competing hep C candidate: telaprevir. Report (WSJ sub. req.)

Related Articles:
Idenix shares soar on positive hep C study data. Report
Idenix hep C therapy misses endpoints in two trials. Report
The best (and worst) biotech stocks of 2006. Report
Idenix, Novartis hepatitis drug meets trial goal. Report
Idenix CFO resigns. Report

ALSO NOTED: Repros reports positive data; Sanofi-Aventis would buy if it could; Vertex gains $25M milestone; and much more...

Wed, 20 Dec 2006 19:01:30 -0500

> Repros Therapeutics saw its stock price jump on the news of positive data from a trial of its experimental therapy for uterine fibroid symptoms. Report

> The CEO of Sanofi-Aventis says he would buy a biotech company, if he could just find one with three or four products. Report

> Merck and Vertex started a mid-stage trial of MK-0457 for leukemia, triggering a $25 million milestone payment to Vertex. Report

> Point Therapeutics has finalized progression-free survival, survival and response data from its completed Phase II study of talabostat in combination with docetaxel in patients with Stage IIIB/IV non-small cell lung cancer. Release

> Critical Therapeutics announced that Frank E. Thomas has been promoted to the position of CEO. Release

> The FDA has approved Merck's INVANZ, a once-daily injectable antibiotic, for a new indication: The prophylaxis of surgical site infection following elective colorectal surgery in adults. Release

> Pherin Pharmaceuticals is reporting positive clinical trial results from a Phase II study of PH80 for treating symptoms of PMS. Release

> Bausch & Lomb has acquired the OTC allergy franchise of Alimera Sciences. Report

> The FDA has approved Anika's injectable soft-tissue filler. Report

And Finally…The Battelle National Biodefense Institute has been selected to run a national biological-threat lab in Maryland. Report

GSK drops out of Vertex pact for HIV therapy

Sun, 17 Dec 2006 19:01:35 -0500

GlaxoSmithKline has dropped out of its pact with Vertex to develop the experimental HIV drug brecanavir, saying it will be too difficult to develop the proper formulation of the drug. The therapy is in mid-stage trials. Vertex notes that the two companies have been collaborating since 1993 and have developed two approved therapies for HIV.

- here's the AP report on GSK's move

Related Article:
Vertex shares jump on hep C trial data. Report

Data on Vertex hep C drug impresses in Phase IIb

Tue, 12 Dec 2006 19:01:36 -0500

Vertex has posted impressive new interim data from a Phase IIb trial of VX-950 (telaprevir) for hepatitis C, renewing hopes that the company is on to a striking success. Almost nine in 10 of the 74 patients receiving VX-950 in combination with long-acting interferon and the antiviral drug ribavirin demonstrated undetectable levels of the virus after 12 weeks of therapy compared to 52 percent of patients taking long-acting interferon and ribavirin with a placebo. Long-acting interferon and ribavirin are the current gold-standard therapies for hep C.

"This interim analysis of PROVE 1 is an important step forward in the telaprevir clinical development program, as it strongly supports the initiation and conduct of large clinical trials designed to evaluate the safety and antiviral activity of telaprevir," says CEO Joshua Boger, Ph.D.

- here's the release on the data

ALSO: The data was worth a $15 million milestone payment for Vertex. Report

Related Articles:
Vertex inks rich pact with J&J. Report
Vertex refines terms on $300M public offering. Report
Vertex gets good news for RA drug. Report

Concert Pharmaceuticals gathers $48M in new round

Wed, 29 Nov 2006 19:01:35 -0500

Upstart biotech Concert Pharmaceuticals has raised $48 million in its second round of venture capital, adding to the $10 million it raised in round one last July. Flagship Ventures led the round which included Brookside Capital Partners Fund and New Leaf Venture Partners. Three Arch partners, TVM Capital, Skyline Ventures, Greylock Partners and QVT Fund LP also participated. Concert CEO Robert Tung had been vice president of drug discovery at Vertex. The company was launched in April.

"With this additional funding, and these premier new investors, we will be able to systematically exploit our proprietary technology and rapidly advance our diverse pipeline into clinical evaluation," said Tung.

- check out the report on the round from The Boston Business Journal

ALSO: Xanthus Pharmaceuticals of Cambridge, MA raised $25 million in its second round. Xanthus has five oncology therapies in its pipeline. Release

Related Article:
Biotech takes top slot in latest venture report. Report

DEALS: J&J buys Pfizer's OTC division for $16.6B

Wed, 05 Jul 2006 20:01:32 -0400

J&J buys Pfizer's OTC division for $16.6B

DEALS
WHO	WITH	WHAT	SCOOP
Pfizer	Johnson & Johnson	$16.6B sale	Pfizer has sold its OTC division to J&J for $16.6 billion in cash.
Siemens	Bayer Healthcare	$5.3B buyout	Siemens has purchased the diagnostics division of Bayer Healthcare. The move is expected to help Bayer complete the acquisition of Schering.
Barr Pharmaceuticals	Pliva	$2.2B buyout	Barr Pharmaceuticals beat out Actavis Group when generic drug maker Pliva announced that it accepted Barr's $2.2 billion buyout offer.
Johnson & Johnson	Vertex	Collaboration deal	The companies will collaborate to develop VX-950 for hepatitis C. Vertex gains $165 million and up to $380 million in milestone payments.
Takeda	Affymax	$535M deal	Takeda will pay Affymax up to $535 million for the worldwide rights--excluding Japan--to Hematide, a therapy for anemia in cancer and kidney disease patients.
Sanofi-Aventis	Taiho	$360M deal	The deal is for most of the global rights to Taiho's S-1 cancer therapy for colorectal, head and neck cancer
Johnson & Johnson	Metabolex	Licensing deal	Johnson & Johnson is buying into Metabolex's program for diabetes and other metabolic conditions with a new collaboration pact that provides a $40 million equity stake and up to $508 million in milestones.
Mayne Pharma	SuperGen	Licensing deal	Mayne has bought North American rights to the leukemia drug Nipent and a medical surface cleaner from SuperGen for $15 million up front and up to $19 million in milestone payments.
Skyepharma	Mundipharma International Holdings	$5M licensing deal	Skyepharma bought back European rights to DepoBupivacaine for its experimental pain drug DepoBupivacaine.
Eli Lilly	Inpharmatica	Licensing deal	Eli Lilly has licensed Admensa Interactive, Inpharmatica's suite of predictive drug absorption, distribution, metabolism and excretion (ADME) models and compound prioritization tools.

Vertex inks rich pact with J&J

Thu, 29 Jun 2006 20:01:37 -0400

Shares of Vertex soared on the news that it has inked a collaboration deal with Johnson & Johnson to develop VX-950 for hepatitis C. Vertex gains $165 million and up to $380 million in milestone payments. Vertex retains North American development rights to the drug.

- read the AP report

ALSO NOTED: Study finds for-profit bias; TorreyPines gets positive data in Phase I; and much more...

Tue, 16 May 2006 20:00:50 -0400

> A new study concludes that clinical trials funded by drug companies are more likely to lead to positive results than trials funded by not-for-profit groups. Report

> TorryPines says its Phase I trial for its therapeutic candidate for acute migraines has produced positive data. Report

> Cambridge, MA-based Vertex has launched a Phase I trial of VX-770 as a therapy for cystic fibrosis. Report

> Amarin has acquired global rights to a novel oral formulation of apomorphine for the treatment of "off" episodes in patients with advanced Parkinson's disease. Release

> Genentech will collaborate with Immunogen to develop a manufacturing process for Herceptin. Release

> Intercept Pharmaceuticals has garnered $41 million in equity financing. The financing was led by Milan-based Genextra. Release

> PrimeGen Biotech has created a wholly owned subsidiary--PrimeCell Therapeutics. Release

And Finally… Indonesia has reported five more deaths from bird flu. Article

Novartis inks $525M hep C deal

Tue, 28 Mar 2006 19:01:39 -0500

Novartis has inked a deal to pay Idenix up to $525 million for the rights to an experimental therapy for hepatitis C. The news comes fast on the heels of an announcement from Idenix--which is 56 percent owned by Novartis--that clinical trials of valopicitabine (NM283) had run into trouble. Some analysts see the licensing deal as a way for Novartis to display its confidence in the program at a critical point. Novartis will pay $25 million up front, with $45 million tied to Phase III. Researchers have had to modify a Phase II trial of the drug after patients receiving the highest dose developed gastrointestinal side effects. Vertex and Schering-Plough are also in the race to test new therapies for hepatitis C. Idenix and Novartis are also pursuing new drug targets for hepatitis B.

- read this Dow Jones report

Vertex shares jump on hep C trial data

Tue, 07 Feb 2006 19:01:36 -0500

Shares of Vertex surged on Tuesday after the drug developer reported positive results for its Phase II trial of VX-950, its hepatitis C drug candidate. After 28 days of treatment, none of the 12 patients taking VX-950 in combination with two other standard therapies had signs of the virus in their blood. Vertex CEO Joshua Boger called the data "surprisingly good." Final results will be released later in the year.

- read this MarketWatch report